Clinical research associate

Terumo is an Equal Opportunity Employer LOCATION: Somerset, New Jersey Our company is growing and we have several CRA openings to support a new clinical project.

Currently we have (2) CRA II openings and (1) CRA I/Office based opening.

If you have CRA experience and are interested in joining a growing organization with the opportunity to be part of a dynamic Clinical Affairs team apply today!

TITLE: Clinical Research Associate (Levels I & II) CRA I Office Based CRA II Remote RESPONSIBILITIES: PURPOSE: Ensure clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements by engaging with assigned sites.

JOB DETAILS:
• Perform site selection, start-up/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices, applicable regulations, SOPs and work instructions.

• Complete appropriate therapeutic, protocol and clinical research training to perform job duties.

• Administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.

• Evaluate the quality and integrity of study site practices related to the proper conduct of the study and adherence to applicable regulations.

Escalate quality issues to Manager, Clinical Affairs.

• Execute assigned work efficiently and adhere to project timelines and financial goals.

• Manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.

• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.

• May provide assistance to less experienced clinical staff, including demonstrating appropriate interactions with sites, documentation and other monitoring activities.

• Frequent travel to sites.

• Perform other duties and responsibilities as assigned.

Working Conditions: This position exists in an office environment.

Position Requirements: Required Knowledge, Skills & Abilities (KSAs):
• Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and ISO 14155.

• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.

• Strong written and verbal communication skills in applicable languages), and business level command of English.

• Good organizational, interpersonal and problem-solving skills.

• Strong attention to detail.

• Working time management skills.

• Ability to establish and maintain effective working relationships with coworkers, managers and clients and site personnel at assigned sites.

Background experiences:
• Bachelor’s Degree, preferably in life science, and minimum of 3 years of monitoring experience required; preferably in medical device, or equivalent combination of education, training and experience.

• IDE-PMA and/or IDE-510k monitoring experience strongly preferred.

• ACRP certification desired.